Autoinjector

ABSTRACT

Described is an autoinjector comprising a case, a door hingedly coupled to the case and having an open position and a closed position, a plunger slidably disposed in the case, and at least one drive spring applying a biasing force on the plunger relative to the case, wherein the door is operably coupled to the plunger, and wherein rotation of the door from the closed position to the open position moves the plunger from a distal position in the case to a proximal position in the case and compresses the at least one drive spring.

This application is a continuation of U.S. patent application Ser. No.14/440,819, filed May 5, 2015, which is a 371 U.S. National Applicationof PCT/EP2013/072897, filed on Nov. 4, 2013, which claims priority toEuropean Patent Application No. 12191442.8, filed on Nov. 6, 2012, theentire contents of which are incorporated herein by reference.

TECHNICAL FIELD The invention relates to an autoinjector foradministering a medicament. BACKGROUND OF THE INVENTION

Administering an injection is a process which presents a number of risksand challenges for users and healthcare professionals, both mental andphysical. Injection devices typically fall into two categories—manualdevices and autoinjectors. In a conventional manual device, manual forceis required to drive a medicament through a needle. This is typicallydone by some form of button/plunger that has to be continuously pressedduring the injection. There are numerous disadvantages associated withthis approach. For example, if the button/plunger is releasedprematurely, the injection will stop and may not deliver an intendeddose. Further, the force required to push the button/plunger may be toohigh (e.g., if the user is elderly or a child). And, aligning theinjection device, administering the injection and keeping the injectiondevice still during the injection may require dexterity which somepatients (e.g., elderly patients, children, arthritic patients, etc.)may not have.

Autoinjector devices aim to make self-injection easier for patients. Aconventional autoinjector may provide the force for administering theinjection by a spring, and trigger button or other mechanism may be usedto activate the injection. Autoinjectors may be single-use or reusabledevices.

Conventional electro-mechanical or fully electronic autoinjectors maynot be as robust as fully mechanical autoinjectors. For example,electro-mechanical or fully electronic autoinjectors may includebatteries which require replacement and may be more difficult orimpossible to fix if a component breaks.

Thus, there remains a need for an improved autoinjector.

SUMMARY OF THE INVENTION

It is an object of the present invention to provide an improvedautoinjector.

In an exemplary embodiment, an autoinjector according to the presentinvention comprises a case, a door hingedly coupled to the case andhaving an open position and a closed position, a plunger slidablydisposed in the case, and at least one drive spring applying a biasingforce on the plunger relative to the case. The door is operably coupledto the plunger, and rotation of the door from the closed position to theopen position moves the plunger from a distal position in the case to aproximal position in the case and compresses the at least one drivespring.

In an exemplary embodiment, an autoinjector according to the presentinvention further comprises a trigger button disposed on the case andoperably coupled to the plunger.

In an exemplary embodiment, an autoinjector according to the presentinvention further comprises an interlock sleeve slidably disposed in thecase and having an extended position and a retracted position relativeto the case. The interlock sleeve includes at least one interlock beamextending axially in the case. In an exemplary embodiment, anautoinjector according to the present invention further comprises atleast one resilient button locking beam disposed in the case and adaptedto engage the at least one interlock beam. The interlock beam causes thebutton locking beam to deflect when the interlock sleeve is in theretracted position. In an exemplary embodiment, an autoinjectoraccording to the present invention further comprises at least onetrigger button beam operably coupled to the trigger button, and the atleast one trigger button beam abuts the at least one button locking beamwhen the interlock sleeve is in the extended position. The at least onetrigger button beam causes the at least one tongue to disengage theratchet face when the trigger button is actuated and the interlocksleeve is in the retracted position.

In an exemplary embodiment, the plunger includes a transverse beam, apiston rod extending from the transverse beam, and at least one legextending from the transverse beam and parallel to the piston rod. Theat least one leg includes a distal foot adapted to support the at leastone drive spring. The at least one leg includes a ratchet face having aplurality of teeth. In an exemplary embodiment, an autoinjectoraccording to the present invention further comprises at least oneresilient tongue disposed in the case and having a hook adapted toengage a tooth on the ratchet face.

In an exemplary embodiment, an autoinjector according to the presentinvention further comprises at least one lever hingedly coupled to thedoor, and at least one roller rotatably coupled to the lever. The rolleris disposed in a track formed in the case.

In an exemplary embodiment, an autoinjector according to the presentinvention further comprises a retraction collar adapted to engage aneedle boot on a syringe. When the door is rotated from the openposition to the closed position, the at least one lever engages theretraction collar to push the needle boot at least partially through anaperture of the interlock sleeve.

The term “drug” or “medicament”, as used herein, means a pharmaceuticalformulation containing at least one pharmaceutically active compound,

wherein in one embodiment the pharmaceutically active compound has amolecular weight up to 1500 Da and/or is a peptide, a proteine, apolysaccharide, a vaccine, a DNA, a RNA, an enzyme, an antibody or afragment thereof, a hormone or an oligonucleotide, or a mixture of theabove-mentioned pharmaceutically active compound,

wherein in a further embodiment the pharmaceutically active compound isuseful for the treatment and/or prophylaxis of diabetes mellitus orcomplications associated with diabetes mellitus such as diabeticretinopathy, thromboembolism disorders such as deep vein or pulmonarythromboembolism, acute coronary syndrome (ACS), angina, myocardialinfarction, cancer, macular degeneration, inflammation, hay fever,atherosclerosis and/or rheumatoid arthritis,

wherein in a further embodiment the pharmaceutically active compoundcomprises at least one peptide for the treatment and/or prophylaxis ofdiabetes mellitus or complications associated with diabetes mellitussuch as diabetic retinopathy,

wherein in a further embodiment the pharmaceutically active compoundcomprises at least one human insulin or a human insulin analogue orderivative, glucagon-like peptide (GLP-1) or an analogue or derivativethereof, or exendin-3 or exendin-4 or an analogue or derivative ofexendin-3 or exendin-4.

Insulin analogues are for example Gly(A21), Arg(B31), Arg(B32) humaninsulin; Lys(B3), Glu(B29) human insulin; Lys(B28), Pro(B29) humaninsulin; Asp(B28) human insulin; human insulin, wherein proline inposition B28 is replaced by Asp, Lys, Leu, Val or Ala and wherein inposition B29 Lys may be replaced by Pro; Ala(B26) human insulin;Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) humaninsulin.

Insulin derivates are for example B29-N-myristoyl-des(B30) humaninsulin; B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl humaninsulin; B29-N-palmitoyl human insulin; B28-N-myristoyl LysB28ProB29human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin;B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl-ThrB29LysB30human insulin; B29-N-(N-palmitoyl-Y-glutamyl)-des(B30) human insulin;B29-N-(N-lithocholyl-Y-glutamyl)-des(B30) human insulin;B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin andB29-N-(ω-carboxyheptadecanoyl) human insulin.

Exendin-4 for example means Exendin-4(1-39), a peptide of the sequenceH-His-Gly-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln-Met-Glu-Glu-Glu-Ala-Val-Arg-Leu-Phe-Ile-Glu-Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser-NH2.

Exendin-4 derivatives are for example selected from the following listof compounds:

H-(Lys)4-des Pro36, des Pro37 Exendin-4(1-39)-NH2,

H-(Lys)5-des Pro36, des Pro37 Exendin-4(1-39)-NH2,

des Pro36 Exendin-4(1-39),

des Pro36 [Asp28] Exendin-4(1-39),

des Pro36 [IsoAsp28] Exendin-4(1-39),

des Pro36 [Met(O)14, Asp28] Exendin-4(1-39),

des Pro36 [Met(O)14, IsoAsp28] Exendin-4(1-39),

des Pro36 [Trp(O2)25, Asp28] Exendin-4(1-39),

des Pro36 [Trp(O2)25, IsoAsp28] Exendin-4(1-39),

des Pro36 [Met(O)14 Trp(O2)25, Asp28] Exendin-4(1-39),

des Pro36 [Met(O)14 Trp(O2)25, IsoAsp28] Exendin-4(1-39); or

des Pro36 [Asp28] Exendin-4(1-39),

des Pro36 [IsoAsp28] Exendin-4(1-39),

des Pro36 [Met(O)14, Asp28] Exendin-4(1-39),

des Pro36 [Met(O)14, IsoAsp28] Exendin-4(1-39),

des Pro36 [Trp(O2)25, Asp28] Exendin-4(1-39),

des Pro36 [Trp(O2)25, IsoAsp28] Exendin-4(1-39),

des Pro36 [Met(O)14 Trp(O2)25, Asp28] Exendin-4(1-39),

des Pro36 [Met(O)14 Trp(O2)25, IsoAsp28] Exendin-4(1-39),

wherein the group -Lys6-NH2 may be bound to the C-terminus of theExendin-4 derivative;

or an Exendin-4 derivative of the sequence

des Pro36 Exendin-4(1-39)-Lys6-NH2 (AVE0010),

H-(Lys)6-des Pro36 [Asp28] Exendin-4(1-39)-Lys6-NH2,

des Asp28 Pro36, Pro37, Pro38Exendin-4(1-39)-NH2,

H-(Lys)6-des Pro36, Pro38 [Asp28] Exendin-4(1-39)-NH2,

H-Asn-(Glu)5des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1-39)-NH2,

des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1-39)-(Lys)6-NH2,

H-(Lys)6-des Pro36, Pro37, Pro38 [Asp28]Exendin-4(1-39)-(Lys)6-NH2,

H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Asp28]Exendin-4(1-39)-(Lys)6-NH2,

H-(Lys)6-des Pro36 [Trp(O2)25, Asp28] Exendin-4(1-39)-Lys6-NH2,

H-des Asp28 Pro36, Pro37, Pro38 [Trp(O2)25]Exendin-4(1-39)-NH2,

H-(Lys)6-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28] Exendin-4(1-39)-NH2,

H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28]Exendin-4(1-39)-NH2,

des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28]Exendin-4(1-39)-(Lys)6-NH2,

H-(Lys)6-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28]Exendin-4(1-39)-(Lys)6-NH2,

H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28]Exendin-4(1-39)-(Lys)6-NH2,

H-(Lys)6-des Pro36 [Met(O)14, Asp28] Exendin-4(1-39)-Lys6-NH2,

des Met(O)14 Asp28 Pro36, Pro37, Pro38 Exendin-4(1-39)-NH2,

H-(Lys)6-desPro36, Pro37, Pro38 [Met(O)14, Asp28] Exendin-4(1-39)-NH2,

H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(O)14, Asp28]Exendin-4(1-39)-NH2,

des Pro36, Pro37, Pro38 [Met(O)14, Asp28] Exendin-4(1-39)-(Lys)6-NH2,

H-(Lys)6-des Pro36, Pro37, Pro38 [Met(O)14, Asp28]Exendin-4(1-39)-(Lys)6-NH2,

H-Asn-(Glu)5 des Pro36, Pro37, Pro38 [Met(O)14, Asp28]Exendin-4(1-39)-(Lys)6-NH2,

H-Lys6-des Pro36 [Met(O)14, Trp(O2)25, Asp28] Exendin-4(1-39)-Lys6-NH2,

H-des Asp28 Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25]Exendin-4(1-39)-NH2,

H-(Lys)6-des Pro36, Pro37, Pro38 [Met(O)14, Asp28] Exendin-4(1-39)-NH2,

H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25, Asp28]Exendin-4(1-39)-NH2,

des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25, Asp28]Exendin-4(1-39)-(Lys)6-NH2,

H-(Lys)6-des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25, Asp28]Exendin-4(S1-39)-(Lys)6-NH2,

H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25, Asp28]Exendin-4(1-39)-(Lys)6-NH2;

or a pharmaceutically acceptable salt or solvate of any one of theafore-mentioned Exendin-4 derivative.

Hormones are for example hypophysis hormones or hypothalamus hormones orregulatory active peptides and their antagonists as listed in RoteListe, ed. 2008, Chapter 50, such as Gonadotropine (Follitropin,Lutropin, Choriongonadotropin, Menotropin), Somatropine (Somatropin),Desmopressin, Terlipressin, Gonadorelin, Triptorelin, Leuprorelin,Buserelin, Nafarelin, Goserelin.

A polysaccharide is for example a glucosaminoglycane, a hyaluronic acid,a heparin, a low molecular weight heparin or an ultra low molecularweight heparin or a derivative thereof, or a sulphated, e.g. apoly-sulphated form of the above-mentioned polysaccharides, and/or apharmaceutically acceptable salt thereof. An example of apharmaceutically acceptable salt of a poly-sulphated low molecularweight heparin is enoxaparin sodium.

Antibodies are globular plasma proteins (˜150 kDa) that are also knownas immunoglobulins which share a basic structure. As they have sugarchains added to amino acid residues, they are glycoproteins. The basicfunctional unit of each antibody is an immunoglobulin (Ig) monomer(containing only one Ig unit); secreted antibodies can also be dimericwith two Ig units as with IgA, tetrameric with four Ig units liketeleost fish IgM, or pentameric with five Ig units, like mammalian IgM.

The Ig monomer is a “Y”-shaped molecule that consists of fourpolypeptide chains; two identical heavy chains and two identical lightchains connected by disulfide bonds between cysteine residues. Eachheavy chain is about 440 amino acids long; each light chain is about 220amino acids long. Heavy and light chains each contain intrachaindisulfide bonds which stabilize their folding. Each chain is composed ofstructural domains called Ig domains. These domains contain about 70-110amino acids and are classified into different categories (for example,variable or V, and constant or C) according to their size and function.They have a characteristic immunoglobulin fold in which two β sheetscreate a “sandwich” shape, held together by interactions betweenconserved cysteines and other charged amino acids.

There are five types of mammalian Ig heavy chain denoted by α, δ, ϵ, γ,and μ. The type of heavy chain present defines the isotype of antibody;these chains are found in IgA, IgD, IgE, IgG, and IgM antibodies,respectively.

Distinct heavy chains differ in size and composition; a and y containapproximately 450 amino acids and δ approximately 500 amino acids, whileμ and ϵ have approximately 550 amino acids. Each heavy chain has tworegions, the constant region (C_(H)) and the variable region (V_(H)). Inone species, the constant region is essentially identical in allantibodies of the same isotype, but differs in antibodies of differentisotypes. Heavy chains γ, α and δ have a constant region composed ofthree tandem Ig domains, and a hinge region for added flexibility; heavychains μ and ϵ have a constant region composed of four immunoglobulindomains. The variable region of the heavy chain differs in antibodiesproduced by different B cells, but is the same for all antibodiesproduced by a single B cell or B cell clone. The variable region of eachheavy chain is approximately 110 amino acids long and is composed of asingle Ig domain.

In mammals, there are two types of immunoglobulin light chain denoted byλ and κ. A light chain has two successive domains: one constant domain(CL) and one variable domain (VL). The approximate length of a lightchain is 211 to 217 amino acids. Each antibody contains two light chainsthat are always identical; only one type of light chain, κ or λ, ispresent per antibody in mammals.

Although the general structure of all antibodies is very similar, theunique property of a given antibody is determined by the variable (V)regions, as detailed above. More specifically, variable loops, threeeach the light (VL) and three on the heavy (VH) chain, are responsiblefor binding to the antigen, i.e. for its antigen specificity. Theseloops are referred to as the Complementarity Determining Regions (CDRs).Because CDRs from both VH and VL domains contribute to theantigen-binding site, it is the combination of the heavy and the lightchains, and not either alone, that determines the final antigenspecificity.

An “antibody fragment” contains at least one antigen binding fragment asdefined above, and exhibits essentially the same function andspecificity as the complete antibody of which the fragment is derivedfrom. Limited proteolytic digestion with papain cleaves the Ig prototypeinto three fragments. Two identical amino terminal fragments, eachcontaining one entire L chain and about half an H chain, are the antigenbinding fragments (Fab). The third fragment, similar in size butcontaining the carboxyl terminal half of both heavy chains with theirinterchain disulfide bond, is the crystalizable fragment (Fc). The Fccontains carbohydrates, complement-binding, and FcR-binding sites.Limited pepsin digestion yields a single F(ab′)2 fragment containingboth Fab pieces and the hinge region, including the H-H interchaindisulfide bond. F(ab′)2 is divalent for antigen binding. The disulfidebond of F(ab′)2 may be cleaved in order to obtain Fab′. Moreover, thevariable regions of the heavy and light chains can be fused together toform a single chain variable fragment (scFv).

Pharmaceutically acceptable salts are for example acid addition saltsand basic salts. Acid addition salts are e.g. HCl or HBr salts. Basicsalts are e.g. salts having a cation selected from alkali or alkaline,e.g. Na+, or K+, or Ca2+, or an ammonium ion N+(R1)(R2)(R3)(R4), whereinR1 to R4 independently of each other mean: hydrogen, an optionallysubstituted C1-C6-alkyl group, an optionally substituted C2-C6-alkenylgroup, an optionally substituted C6-C10-aryl group, or an optionallysubstituted C6-C10-heteroaryl group. Further examples ofpharmaceutically acceptable salts are described in “Remington'sPharmaceutical Sciences” 17. ed. Alfonso R. Gennaro (Ed.), MarkPublishing Company, Easton, Pa., U.S.A., 1985 and in Encyclopedia ofPharmaceutical Technology.

Pharmaceutically acceptable solvates are for example hydrates.

Further scope of applicability of the present invention will becomeapparent from the detailed description given hereinafter. However, itshould be understood that the detailed description and specificexamples, while indicating preferred embodiments of the invention, aregiven by way of illustration only, since various changes andmodifications within the spirit and scope of the invention will becomeapparent to those skilled in the art from this detailed description.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will become more fully understood from thedetailed description given hereinbelow and the accompanying drawingswhich are given by way of illustration only, and thus, are not limitiveof the present invention, and wherein:

FIG. 1 is a perspective view of an exemplary embodiment of anautoinjector according to the present invention,

FIG. 2 is a perspective detail view of an exemplary embodiment of anautoinjector according to the present invention prior to use,

FIG. 3 is a perspective detail view of an exemplary embodiment of anautoinjector according to the present invention prior to use,

FIG. 4 is a perspective detail view of an exemplary embodiment of anautoinjector according to the present invention prior to use,

FIG. 5 is a perspective view of an exemplary embodiment of a syringe foruse with an autoinjector according to the present invention,

FIG. 6 is a perspective view of an exemplary embodiment of a syringe foruse with an autoinjector according to the present invention,

FIG. 7 is a perspective view of an exemplary embodiment of a syringe foruse with an autoinjector according to the present invention,

FIG. 8 is a perspective view of an exemplary embodiment of anautoinjector according to the present invention prior to use,

FIG. 9 is a perspective view of an exemplary embodiment of anautoinjector according to the present invention prior to use,

FIG. 10 is a perspective view of an exemplary embodiment of anautoinjector according to the present invention prior to use,

FIG. 11 is a perspective view of an exemplary embodiment of anautoinjector according to the present invention during use,

FIG. 12 is a perspective view of an exemplary embodiment of anautoinjector according to the present invention during use,

FIG. 13 is a perspective view of an exemplary embodiment of anautoinjector according to the present invention during use,

FIG. 14 is a perspective view of an exemplary embodiment of anautoinjector according to the present invention after use,

FIG. 15 is a perspective view of an exemplary embodiment of anautoinjector according to the present invention after use,

FIG. 16 is a perspective view of an exemplary embodiment of a needleshield release mechanism according to the present invention in aretracted position,

FIG. 17 is a perspective view of an exemplary embodiment of a needleshield according to the present invention in an extended position,

FIG. 18 is a perspective view of an exemplary embodiment of anengagement of a needle shield and a case of an autoinjector according tothe present invention,

FIGS. 19A-B are perspective views of an exemplary embodiment of asyringe retraction mechanism according to the present invention, and

FIGS. 20A-B are perspective views of an exemplary embodiment of a driverelease mechanism according to the present invention.

Corresponding parts are marked with the same reference symbols in allfigures.

DETAILED DESCRIPTION

FIG. 1 is a perspective semitransparent view of an exemplary embodimentof an autoinjector 1 according to the present invention.

In an exemplary embodiment, the autoinjector 1 comprises a case 2designed to be held by a patient, health-care provider or other userduring an injection. The case 2 may have a generally elongate,rectangular shape and may include one or more ergonomic features (e.g.,finger grooves for gripping) and/or textured surfaces or skins forpreventing a user's hand from slipping while using the autoinjector 1.

In an exemplary embodiment, the case 2 includes a door 3 which isconfigurable in an open position or a closed position. In the openposition, the door 3 provides access to a syringe carrier in the case 2that is adapted to hold a syringe 6 or a cartridge containing amedicament. In the closed position, the door 3 may be locked. As shownin the exemplary embodiment in FIG. 1, the door 3 may be formed on aside of the case 2 and rotate about a transverse hinge between the openand closed positions. However, those of skill in the art will understandthat the door 3 may be formed on any side or face of the case 2 and mayrotate, slide or translate relative to the case 2 to open and close.

In an exemplary embodiment, a door spring may be arranged in the case 2to bias the door 3 to the open position. A door latch may be formed onthe case 2 and/or the door 3 to maintain the door 3 in the closedposition. In an exemplary embodiment, the door latch may be rotated ordeflected to engage/disengage the case 2 and/or the door 3 to allow thedoor 3 to open and close. When the door 3 is in the open position, aused syringe may be removed from the syringe carrier and a new syringemay be inserted into the syringe carrier.

In an exemplary embodiment, at least one drive spring 9 is disposed inthe case 2. In the exemplary embodiment shown in FIG. 1, two drivesprings 9 are compression springs disposed in parallel in the case 2.Those of skill in the art will understand that other exemplaryembodiments may utilize a single drive spring, and one or more tensionor torsion drive springs.

In an exemplary embodiment, the drive springs 9 apply a biasing force ona plunger 10.

The plunger 10 comprises a piston rod 10.1 projecting distally from atransverse beam 10.3 and two legs 10.2 projecting distally from opposinglateral portions of the transverse beam 10.3 and parallel to the pistonrod 10.1. In the exemplary embodiment, each drive spring 9 is positionedbetween a proximal end of the case 2 and a distal foot 10.4 of each leg10.2.

In an exemplary embodiment, at least one lever 11 is hingedly coupled tothe door 3 at a first end via a pivot 12 and engages a roller 13 at asecond end. The roller 13 may be disposed in an axial track 14 which isformed in the case 2, and the roller 13 may be adapted to engage thedistal foot 10.4 of the leg 10.2 of the plunger 10 when the door 3 ismoved from the closed position to the open position. In anotherexemplary embodiment, the second end of the lever 11 may engage thetrack 14 and be axially moveable relative thereto. A projection orabutment surface may be coupled to the second end of the lever 11 andadapted to engage the distal foot 10.4 of the leg 10.2.

As explained further below, the door 3 and the levers 11 may be utilizedas a reset mechanism.

FIG. 2 shows an exemplary embodiment of an autoinjector 1 according tothe present invention. In the exemplary embodiment shown in FIG. 2, thedoor 3 is in the opened position, and a roller 13 is abutting the distalfoot 10.4 of each leg 10.2. In the exemplary embodiment, each leg 10.2includes a ratchet face 10.5 having teeth that are adapted to engage ahook 15.1 on a resilient tongue 15. The tongue 15 may be an elongatemember formed in the case 2 which is fixed at one end and deflectable atan opposite end having the hook 15.1, and the tongue 15 may be biasedtoward the leg 10.2. Thus, as the leg 10.2 is moving in the proximaldirection, the teeth on the ratchet face 10.5 may engage the hook 15.1to prevent the plunger 10 from moving in the distal direction during areset operation and/or while moving the door 3 from the closed positionto the open position. Those of skill in the art will understand that theteeth on the ratchet face 10.5 and the hook 15.1 may have correspondingramped engagement surfaces to reduce a force required to open the door3.

FIG. 2 also shows an exemplary embodiment of guide pins 10.6 which maybe formed on a proximal end of the case 2 and project in a distaldirection through holes in the transverse beam 10.3. The guide pins 10.6may provide support and alignment for the drive springs 9.

FIG. 3 shows an exemplary embodiment of an autoinjector 1 according tothe present invention. In the exemplary embodiment shown in FIG. 3, theplunger 10 has been fully translated in the proximal direction P, thedrive springs 9 have been compressed, the hooks 15.1 have engaged adistal-most tooth on each ratchet face 10.5, and the door 3 is beingclosed.

Referring again to FIG. 1, the autoinjector 1 includes a trigger button(not visible in the figures) arranged on the case 2. The trigger buttonserves for starting an injection process when actuated. The triggerbutton may be a push button, a switch, a dial (e.g., to vary needlepenetration depth), etc. The trigger button may be arranged on aproximal end of the case 2 or a side of the case. In another exemplaryembodiment, the trigger button may be replaced by a push-actuateddevice, which is actuated when the autoinjector 1 is placed on theinjection site. In an exemplary embodiment, a spring biases the triggerbutton relative to the case 2.

In an exemplary embodiment, the autoinjector 1 includes an interlocksleeve 17 slidably disposed in the case 2. The interlock sleeve 17includes a distal end which protrudes from an aperture formed in adistal end of the case 2. The distal end of the interlock sleeve 17includes an aperture 17.2 for allowing a needle to pass through duringneedle insertion into the injection site. The distal end of theinterlock sleeve 17 may further include an expanded contact face tosupport proper alignment of the autoinjector 1 on the injection site andprovide additional stability during the injection.

The interlock sleeve 17 may be biased by a spring in an extendedposition, which position is shown in the exemplary embodiment in FIG. 1.When the autoinjector 1 is placed on the injection site, interlocksleeve 17 may be pushed in the proximal direction into a retractedposition against the biasing force of the spring.

FIGS. 3 and 4 show an exemplary embodiment of the autoinjector 1according to the present invention in which the trigger button isoperably coupled to the interlock sleeve 17. For example, when theinterlock sleeve 17 is in the extended position, the trigger button maybe locked and prevented from actuation. When the interlock sleeve 17 isin the retracted position, the trigger button may be unlocked andactuatable.

In an exemplary embodiment, two interlock beams 17.1 extend in theproximal direction from the distal end of the interlock sleeve 17. In anexemplary embodiment, the interlock beams 17.1 are maintained on aninside of the case 2, and may include abutment surfaces which engage adistal end of the case 2 when the interlock sleeve 17 is in the extendedposition. Proximal ends of the interlock beams 17.1 include rampedsurfaces which engage corresponding ramped surfaces of resilient buttonlocking beams 18 disposed in the case 2. When the interlock sleeve 17moves from the extended position to the retracted position, the proximalends of the interlock beams 17.1 cause the button locking beams 18 todeflect.

In a non-deflected state, the button locking beams 18 are adapted toengage distal ends of trigger button beams 16, which are operablycoupled to the trigger button, and prevent the trigger button beams 16from moving in the distal direction. When the button locking beams 18are deflected, the trigger button beams 16 may move in the distaldirection. The distal ends of the trigger button beams 16 are in rampedengagement with the resilient tongues 15. Thus, axial movement of thetrigger button beams 16 causes the resilient tongues 15 to deflectlaterally and disengage the legs 10.2 of the plunger 10.

Thus, in the exemplary embodiment, the trigger button is actuatable whenthe interlock sleeve 17 is in the retracted position. Otherwise, thetrigger button is prevented from actuation, because the button lockingbeams 18 abut the trigger button beams 16, as shown in FIGS. 3 and 4.

Referring again to FIG. 1, in an exemplary embodiment, a door lock 19may be disposed on the case 2. The door lock 19 may be a button, aswitch or other component which maintains the door 3 in the closedposition. As shown in the exemplary embodiment in FIG. 4, the door lock19 has a pin 19.1 which projects into the interior of the case 2. Thedoor lock 19 may have a proximal position in which the pin 19.1 isdisengages from a door hook 3.1 (shown in FIG. 1) and a distal positionin which the pin 19.1 engages the door hook 3.1. The door lock 19 may bebiased (e.g., by a spring) in the distal position, and when the door ismoved from the open position to the closed position, a ramped portion ofthe door hook 3.1 may move the pin 19.1 and the door lock 19 into theproximal position until the door 3 is closed, and then the door lock 19may return (under the biasing force) to the distal position so that thepin 19.1 engages the door hook 3.1 and locks the door 3.

FIGS. 5-7 show an exemplary embodiment of a syringe 6 for use with theautoinjector 1 according to the present invention. The syringe 6includes a body 20 containing a medicament and a case 21 telescopicallycoupled to the body 20. The case 21 may include an attachment (e.g.,hooks, snaps, etc.) which engage a finger flange 20.1 on a proximal endof the body 20. A needle shield 23 is telescopically coupled to the case21 and is biased toward the distal direction relative to the case 21 bya spring 24. The needle shield 23 is retained in its retracted state(shown in FIG. 16) by a pivoted clip 21.1 on the case 21 which in anon-deflected position engages a recess in the needle shield 23 and in adeflected position disengages the recess in the needle shield 23.

Referring to FIG. 6, a needle 22 is disposed at a distal end of the body20. A needle boot 7 is, as shown in FIG. 5, arranged on the needle 22,prior to use. FIG. 6 shows the syringe 6 with the needle boot 7 removedand the needle shield 23 in a retracted position, with the needle 22exposed. FIG. 7 shows the syringe 6 with the needle shield 23 in anextended position, covering a distal tip of the needle 22. The needleshield 23 may be locked in its extended position, as shown in FIG. 17,by a resilient beam 23.2 which is released and abuts the case 21 oncethe shield 23 is in its fully extended position.

In an exemplary embodiment, a data storage device 27 may be disposed onthe syringe 6 and include data, such as a type and volume of themedicament, filling and/or expiration date of the medicament,temperature of the medicament (e.g., if there is a temperature sensor onor near the syringe 4), a manufacturer of the medicament and/or theautoinjector 1, patient data (e.g., name, physician, dosing regiment,etc.), a used/unused indicator, etc. The data storage device 27 mayinterface with a wired or wireless communication device for transmittingthe data to a computing device. The computing device may be used fortracking use/attributes of the syringe 6, e.g., for compliance and/orquality control purposes.

Referring again to FIG. 1, in an exemplary embodiment, the autoinjector1 includes a retraction collar 25 distally supporting the syringe 6 andbiased against the case 2 in the proximal direction P by a retractionspring 26 so that the syringe 6 is biased towards a retracted positionin which the needle 22 is covered within the case 2.

In an exemplary embodiment, the retraction collar 25 is utilized forremoving the needle boot 7 prior to an injection. The retraction collar25 includes a flange which is adapted to engage the needle boot 7. Forexample, the flange may engage a proximal surface on an annular bootcollar 7.1 on the needle boot 7. In an exemplary embodiment, as the door3 is moved from the open position to the closed position, when the door3 is almost closed, the levers 11 and/or the rollers 13 may operablyengage the retraction collar 25 to advance the retraction collar 25 inthe distal direction, against the force of the retraction spring 26. Theneedle boot 7 may then be at least partially disengage from the needle22 and at least partially exposed through the aperture 17.2 in thedistal end of the interlock sleeve 17. As shown in FIG. 18, the syringeassembly 6 is held in place via interference between a boss 21.2 on thesyringe case 21 and a ramped boss 2.1 on the case 2. The force toovercome the interference is higher than the forces generated as thedoor 3 is closed; however it is lower than the drive forces duringdevice firing.

In an exemplary embodiment, the case 2 and/or the door 3 may include aviewing window 28 for allowing inspection of the syringe 6 and itscontents and state.

In an exemplary, non-illustrated embodiment a distal end of the pistonrod 10.1 may comprise resilient elements which may be inwardly deflectedso as to reduce an external diameter of the distal end of the piston rod10.1. In a relaxed position of the resilient elements, the externaldiameter of the distal end of the piston rod 10.1 is slightly greaterthan an internal diameter of the proximal end of the syringe body 20.The resilient elements may be rounded off or ramped so that they may beinwardly deflected when pushing on the proximal end of the syringe body20 and when a counteracting force of the syringe body 20 exceeds apredetermined value. The proximal end of the syringe body 20 may exhibitan internal circumferential collar slightly reducing the internaldiameter of the syringe body 20 and providing an additional detent whichhas to be overcome by the distal end of the piston rod 10.1 before itcan enter the syringe body 20. If the piston rod 10.1 is advanced in thedistal direction, it contacts the collar. As long as the syringe body 20can move in the distal direction the counteracting force from thesyringe body 20 may be too low to deflect the resilient elements. Hence,the piston rod 10.1 advances the syringe body 20 and the whole syringefor extending the needle 22 from the case 2 without pushing on thestopper 8. As the syringe 6 advances the retraction spring 26 iscompressed.

When the needle 22 has reached its insertion depth the syringe 6 bottomsout against a stop in the case 2 thereby suddenly increasing thecounteracting force opposing the force from the piston rod 10.1. Theresilient elements are therefore inwardly deflected by the collardisengaging the piston rod 10.1 from the syringe body 20 and allowing itto advance further and engage the stopper 8 for displacing themedicament from the syringe body 20.

An exemplary sequence of operation of the autoinjector 1 is described inthe following, though those of skill in the art will understand thatvarious steps in the sequence may be conducted in any order and is notlimited to the sequence described below.

FIG. 8 shows an exemplary embodiment of an autoinjector 1 according tothe present invention prior to use. The door 3 is locked in the closedposition, because the door hook 3.1 engages the pin 19.1 on the doorlock 19. The interlock sleeve 17 is in the extended position.

FIG. 9 shows an exemplary embodiment of an autoinjector 1 according tothe present invention prior to use, with the door 3 in the openposition. When the door lock 19 is moved from the distal position to theproximal position, the pin 19.1 disengages the door hook 3.1, and aspring may rotate the door 3 from the closed position. In an exemplaryembodiment, the spring may be forceful enough to move the door 3 to theopen position, or the spring may rotate the door 3 from the closedposition and a user may be required to rotate the door 3 to the fullopen position, as shown in FIG. 9.

When the door 3 is moved from the closed position to the open position,the rollers 13 move proximally along the respective tracks 14, pushingthe legs 10.2 and, thus, the plunger 10 proximally, which compresses thedrive springs 9. When the door 3 is in the open position, thedistal-most teeth on the ratchet face 10.5 of the legs 10.1 engage thehook 15.1 on the resilient tongue 15. As explained above, the teeth onthe ratchet face 10.5 engaging the hook 15.1 prevent the plunger 10 frommoving distally when the door 3 is being opened.

FIG. 10 shows an exemplary embodiment of an autoinjector 1 according tothe present invention prior to use with a syringe 6. In the exemplaryembodiment, the syringe 6 is placed in a syringe carrier which isslidably disposed in the case 2 or in a channel in the case 2 whichallows the syringe 6 to translate relative to the case 2. The syringe 6may be aligned such that the annular boot collar 7.1 on the needle boot7 engages the flange on the retraction collar 25.

FIG. 11 shows an exemplary embodiment of an autoinjector 1 according tothe present invention with an unused syringe 6 in the case 2 and thedoor 3 in the closed position. As the door 3 is moved from the openposition to the closed position, when the door 3 is almost closed, thelevers 11 and/or the rollers 13 may operably engage the retractioncollar 25 to advance the retraction collar 25 in the distal direction,against the force of the retraction spring 26. Thus, when the door 3 isin the closed position, the needle boot 7 may be at least partiallydisengaged from the needle 22 and at least partially exposed through theaperture 17.2 in the distal end of the interlock sleeve 17. The user maythen grip the needle boot 7 and pull it off the needle 22, which mayremain covered by the interlock sleeve 17. When the interlock sleeve 17is in the extended position, the trigger button of the autoinjector 1 islocked, because the trigger button beams 16 abut the interlock beams17.1.

FIG. 12 shows an exemplary embodiment of an autoinjector 1 according tothe present invention during use, when the autoinjector 1 has beenpressed against an injection site. When the autoinjector 1 is pressedagainst an injection site, the interlock sleeve 17 translates in theproximal direction relative to the case 2. As the interlock sleeve 17translates proximally relative to the case 2, the interlock beams 17.2engage the button locking beams 18, causing the button locking beams 18to deflect. Because the button locking beams 18 are deflected, they nolonger prevent the trigger button beams 16 from moving distally relativeto the case 2, and thus the trigger button is operable.

FIG. 13 shows an exemplary embodiment of an autoinjector 1 according tothe present invention during use. When the trigger button is pressed,the trigger button beams 16 move distally relative to the case 2, anddeflect the tongues 15. When the tongues 15 are deflected, the hook 15.1disengages the ratchet faces 10.5 of the legs 10.2, and the plunger 10,under the force of the drive springs 9, moves distally relative to thecase 2. As the plunger 10 moves distally relative to the case 2, itfirst engages the syringe 6 (or the syringe carrier) and pushes thesyringe 6 distally relative to the case 2 for insertion of the needle 22into the injection site. The needle 22 passes through the aperture 17.2in the interlock sleeve 17, as shown in FIG. 13.

When the syringe 6 (or the syringe carrier) abuts a first stop in thecase 2, the remaining force in the drive springs 10 causes the plunger10 to engage and push the stopper 8 in the syringe 6, dispensing themedicament in the syringe 6. In an exemplary embodiment, the plunger 10may engage a second stop in the case 2 to limit its movement relative tothe syringe 6 after the syringe 6 has engaged the first stop.

In an exemplary embodiment, the autoinjector 1 may include one or morefeedback mechanisms which provide visual, audible and/or tactilefeedback regarding progress of the injection. For example, when the hook15.1 disengages the ratchet face 10.5, a clicking sound may be generatedto notify the user that the injection has begun. Visual feedback may beprovided, for example, through the window(s) 28 in the case 2.

When the syringe 6 (or the syringe carrier) abuts the stop in the case2, the retraction spring 26 has been compressed. As shown in FIGS. 19Aand 19B, the retraction collar 25 is held in place by the roller 13.After activation the distal foot 10.4 contacts the roller 13 (FIG. 19A)and the ramped face of the distal foot 10.4 lifts the roller 13 to aplane above the initial contact point of the roller 13 and theretraction collar 25 (FIG. 19B). This allows the retraction spring 26 todrive the syringe 6 back in the proximal direction. Simultaneously, astransverse beam 10.3 reaches its end stop, the legs 10.2 align with agap in the case 2 allowing them to spring out and uncouple thetransverse beam 10.3 from the drive springs 9, as shown in FIGS. 20A and20B.

FIG. 14 shows an exemplary embodiment of an autoinjector 1 according tothe present invention after use. When the autoinjector 1 is removed fromthe injection site (e.g., after a dose of the medicament has beendelivered or for any other reason), the interlock sleeve 17 returns tothe extended state under the force of the spring, the retraction spring26 exerts force on the syringe 6 (or the syringe carrier) to withdrawthe needle 22 from the injection site, and, because the trigger buttonhas been released, the ratchet faces 10.5 engage the legs 10.2 tomaintain the plunger 10 in position relative to the case 2. For example,if the autoinjector 1 is removed from the injection site prior todelivery of the full dose of the medicament, the ratchet faces 10.5 mayengage the hooks 15.1 to prevent the plunger 10 from further advancingthe stopper 8. Also, after the syringe 6 has been retracted, the needleshield 23 is advanced to and locked in the extended position by theneedle shield spring 24, as shown in FIG. 15. Thus, when the door 3 isunlocked (via the door lock 19) and moved to the open position, theneedle 22 is covered by the locked needle shield 23 and does not presentrisk of needle stick injury.

Those of skill in the art will understand that modifications (additionsand/or removals) of various components of the apparatuses, methodsand/or systems and embodiments described herein may be made withoutdeparting from the full scope and spirit of the present invention, whichencompass such modifications and any and all equivalents thereof.

1-15. (canceled)
 16. An autoinjector comprising: a case configured toreceive a syringe; a plunger slidably disposed in the case; and twoparallel compression drive springs disposed on opposite sides of thesyringe and positioned between a proximal end of the case and a distalend of the plunger, the two parallel compression drive springsrespectively defining two axes along which the two parallel compressiondrive springs are compressible and that are parallel to the needleinsertion direction, the two parallel compression drive springsconfigured to apply a biasing force on the plunger relative to the case,and the plunger being configured to advance the syringe relative to thecase and to advance a stopper of the syringe relative to a body of thesyringe when the two parallel compression drive springs apply thebiasing force on the plunger.
 17. The autoinjector of claim 16, furthercomprising: a trigger button disposed on the case and operably coupledto the plunger.
 18. The autoinjector of claim 17, further comprising: aninterlock sleeve slidably disposed in the case and having an extendedposition and a retracted position relative to the case.
 19. Theautoinjector of claim 18, wherein the interlock sleeve comprises atleast one interlock beam extending axially in the case.
 20. Theautoinjector of claim 18, further comprising: at least one resilientbutton locking beam disposed in the case and configured to engage the atleast one interlock beam.
 21. The autoinjector of claim 20, wherein theat least one interlock beam is configured to cause the at least oneresilient button locking beam to deflect when the interlock sleeve is inthe retracted position.
 22. The autoinjector of claim 21, furthercomprising: at least one trigger button beam operably coupled to thetrigger button, wherein the at least one trigger button beam isconfigured to abut the at least one resilient button locking beam whenthe interlock sleeve is in the extended position.
 23. The autoinjectorof claim 16, wherein the plunger comprises: a transverse beam; a pistonrod extending longitudinally from the transverse beam and configured toadvance along the longitudinal axis to engage the stopper of thesyringe; and at least one leg extending from the transverse beam andparallel to the piston rod, the at least one leg comprising a distalfoot and a ratchet face having a plurality of teeth, the distal footbeing configured to support at least one of the two parallel compressiondrive springs.
 24. The autoinjector of claim 23, further comprising: atleast one resilient tongue disposed in the case and having a hookconfigured to engage a tooth of the plurality of teeth.
 25. Theautoinjector of claim 24, further comprising: a trigger button; and atleast one trigger button beam disposed in the case, wherein the at leastone trigger button beam is configured to cause the at least one tonguefrom the ratchet face to disengage from the tooth when the triggerbutton is actuated.
 26. The autoinjector of claim 16, furthercomprising: a door hingedly coupled to the case and having an openposition and a closed position; at least one lever hingedly coupled tothe door; and at least one roller rotatably coupled to the lever. 27.The autoinjector of claim 26, wherein the at least one roller isdisposed in a track formed in the case.
 28. The autoinjector of claim16, further comprising: a retraction collar configured to engage aneedle boot on the syringe.
 29. The autoinjector of claim 28, furthercomprising: a door hingedly coupled to the case and having an openposition and a closed position; and at least one lever hingedly coupledto the door, wherein the at least one lever is configured to engage theretraction collar to push the needle boot at least partially through anaperture of an interlock sleeve slidably disposed in the case when thedoor is rotated from the open position to the closed position.